Latest news with #US-approved
Yahoo
27-05-2025
- General
- Yahoo
Chaos erupts on first day of US-backed aid distribution in Gaza after weeks of hunger
Thousands of Palestinians overran a newly established aid site in southern Gaza on Tuesday that is part of a controversial new Israeli- and US-approved aid distribution mechanism that began on Tuesday after months of blockade. Videos from the distribution site in Tel al-Sultan, run by the Gaza Humanitarian Foundation (GHF), showed large crowds storming the facilities, tearing down some of the fencing and appearing to climb over barriers designed to control the flow of the crowd. A diplomatic official called the chaos at the site 'a surprise to no one.' An 11-week Israeli blockade on humanitarian aid has pushed the enclave's population of more than 2 million Palestinians towards famine and into a deepening humanitarian crisis, with the first resumption of humanitarian aid trickling into the besieged enclave last week. The GHF acknowledged the pandemonium, saying 'the GHF team fell back to allow a small number of Gazans to take aid safely and dissipate. This was done in accordance with GHF protocol to avoid casualties.' A security source said American security contractors on the ground did not fire any shots and that operations would resume at the site on Wednesday. 'It's a big failure that we warned against,' said Amjad al-Shawa, director of Palestinian Non-Governmental Organizations Network. 'If Israel believes that through this blockade and emboldening starvation, which violates humanitarian principles, that this distribution method would work, they are mistaken.' GHF said it has distributed about 8,000 food boxes totaling 462,000 meals in Gaza so far. They say the flow of meals will increase each day, with a goal of delivering food to 1.2 million – 60% of Gaza's population – by the end of the week. The GHF claimed it began operating on Monday, but photos from the organization showed only a handful of people carrying boxes of aid, with pallets of boxes sitting at an otherwise empty lot. GHF is readying three additional sites for the distribution of aid, two of which are in southern Gaza and one in central Gaza. All of the sites in the south are in an area that fell under a massive evacuation order one day earlier. There are no distribution sites in northern Gaza – a point of criticism from many aid experts. The UN has previously warned that the fact the initial sites were only in southern and central Gaza could be seen as encouraging Israel's publicly stated goal of forcing 'the entire Gazan population' out of northern Gaza, as Defense Minister Israel Katz put it earlier this month. 'This mechanism appears practically unfeasible, incompatible with humanitarian principles and will create serious insecurity risks, all while failing to meet Israel's obligations under international law,' the UN Office for the Coordination of Humanitarian Affairs wrote earlier this month in a document obtained by CNN. The United Nations said on Tuesday that Israel continues to deny it authorization to deliver food directly to families in Gaza, but they have thousands of trucks ready to enter the strip. The UN Relief and Works Agency for Palestine Refugees (UNRWA) said it was ready, with other humanitarian organizations, 'to distribute meaningful quantities of aid the moment we are allowed to.' 'The amount of supplies that were permitted to enter the Gaza Strip has been so minimal that they have not even reached families outside of one small area,' UNRWA said in a statement. Israel and the US had declined to name the humanitarian organizations involved in the controversial new mechanism, but images from the GHF showed boxes labeled 'Rahma Worldwide,' a Michigan-based non-profit organization that says it provides 'aid and assistance to the most vulnerable communities in the world.' This is a developing story and will be updated.
CNN
27-05-2025
- General
- CNN
Chaos erupts on first day of US-backed aid distribution in Gaza after weeks of hunger
Thousands of Palestinians overran a newly established aid site in southern Gaza on Tuesday that is part of a controversial new Israeli- and US-approved aid distribution mechanism that began on Tuesday after months of blockade. Videos from the distribution site in Tel al-Sultan, run by the Gaza Humanitarian Foundation (GHF), showed large crowds storming the facilities, tearing down some of the fencing and appearing to climb over barriers designed to control the flow of the crowd. A diplomatic official called the chaos at the site 'a surprise to no one.' An 11-week Israeli blockade on humanitarian aid has pushed the enclave's population of more than 2 million Palestinians towards famine and into a deepening humanitarian crisis, with the first resumption of humanitarian aid trickling into the besieged enclave last week. The GHF acknowledged the pandemonium, saying 'the GHF team fell back to allow a small number of Gazans to take aid safely and dissipate. This was done in accordance with GHF protocol to avoid casualties.' A security source said American security contractors on the ground did not fire any shots and that operations would resume at the site on Wednesday. 'It's a big failure that we warned against,' said Amjad al-Shawa, director of Palestinian Non-Governmental Organizations Network. 'If Israel believes that through this blockade and emboldening starvation, which violates humanitarian principles, that this distribution method would work, they are mistaken.' GHF said it has distributed about 8,000 food boxes totaling 462,000 meals in Gaza so far. They say the flow of meals will increase each day, with a goal of delivering food to 1.2 million – 60% of Gaza's population – by the end of the week. The GHF claimed it began operating on Monday, but photos from the organization showed only a handful of people carrying boxes of aid, with pallets of boxes sitting at an otherwise empty lot. GHF is readying three additional sites for the distribution of aid, two of which are in southern Gaza and one in central Gaza. All of the sites in the south are in an area that fell under a massive evacuation order one day earlier. There are no distribution sites in northern Gaza – a point of criticism from many aid experts. The UN has previously warned that the fact the initial sites were only in southern and central Gaza could be seen as encouraging Israel's publicly stated goal of forcing 'the entire Gazan population' out of northern Gaza, as Defense Minister Israel Katz put it earlier this month. 'This mechanism appears practically unfeasible, incompatible with humanitarian principles and will create serious insecurity risks, all while failing to meet Israel's obligations under international law,' the UN Office for the Coordination of Humanitarian Affairs wrote earlier this month in a document obtained by CNN. The United Nations said on Tuesday that Israel continues to deny it authorization to deliver food directly to families in Gaza, but they have thousands of trucks ready to enter the strip. The UN Relief and Works Agency for Palestine Refugees (UNRWA) said it was ready, with other humanitarian organizations, 'to distribute meaningful quantities of aid the moment we are allowed to.' 'The amount of supplies that were permitted to enter the Gaza Strip has been so minimal that they have not even reached families outside of one small area,' UNRWA said in a statement. Israel and the US had declined to name the humanitarian organizations involved in the controversial new mechanism, but images from the GHF showed boxes labeled 'Rahma Worldwide,' a Michigan-based non-profit organization that says it provides 'aid and assistance to the most vulnerable communities in the world.' This is a developing story and will be updated.
Barnama
28-04-2025
- Business
- Barnama
Germany's Merck Seals US$3.9bln Deal To Buy US Biotech Firm Springworks
07 March 2024, Hesse, Darmstadt: A Merck KGaA brand logo stands in front of the company premises. Photo: Arne Dedert/dpa FRANKFURT, April 28 (Bernama-dpa) - German health care and science group Merck has sealed a deal to bolster its cancer treatment portfolio with a US$3.9 billion acquisition of US biotech firm SpringWorks Therapeutics, German Press Agency (dpa) reported. Chief executive Belén Garijo on Monday called the deal a "major step" for Merck, adding that it will sharpen the company's focus on patients with rare tumours, accelerate company growth, and strengthen its presence in the US. The acquisition is expected to close in the second half of the year, pending approval from SpringWorks shareholders and regulatory authorities. bootstrap slideshow SpringWorks, based in Connecticut, was spun off from Pfizer in 2017 and specialises in therapies for tumours and blood cancers. The company already has a US-approved drug for advanced soft tissue tumours, which may soon gain approval in the European Union. Merck had confirmed advanced discussions with SpringWorks last week. Despite recent growth in its pharmaceuticals division, Merck has faced pressure to bring new drugs to market after several high-profile clinical trial failures. Merck had therefore increasingly focused on licensing other companies' drugs, but recently began considering acquisitions again. Garijo emphasised that Merck is still positioned to pursue further "major transactions" after the SpringWorks deal. Merck's last major acquisition was in 2019, when it bought US semiconductor supplier Versum Materials for approximately US$5.8 billion.
News.com.au
23-04-2025
- Business
- News.com.au
Health Check: Telix shares rocket after bullish quarterly sales update
Telix's quarterly sales reflect first revenue from the company's recent purchase of a US nuclear medicine manufacturer Island Pharma hopes to lift the kimono on its dengue fever trial next month Race Oncology kicks off its cancer-busting, cardioprotective trial Having gleaned all its revenue to date from its US-approved prostate cancer imaging agent Illucix, Telix Pharmaceuticals (ASX:TLX) is starting to reap the benefit of its acquisition of a US nuclear medicine manufacturer. In September last year Telix paid US$230 million for RLS Radiopharmacies, which has 31 nuclear pharmacies dotted across Trumpland. Telix has reported March quarter revenue of US$186 million, 62% higher year on year and 31% up on the December quarter. This includes a robust US$33 million from RLS, which Telix formally acquired on January 27 this year. 'This strategic acquisition has significantly expanded our manufacturing footprint in the US, which we believe is an increasingly important consideration amid changing global trade dynamics,' says Telix chief Dr Chris Behrenbruch. Ah, tariffs! We get it. Illucix sales continue at a decent clip: US$151 million, up 35% year on year. 'Illuccix has continued its momentum, gaining market share and maintaining price stability in a competitive landscape,' Behrenbruch says. Telix has affirmed guidance of full-year (calendar 2025) revenue of US$770-800 million, including eleven months of RLS sales. The guidance is subject to change, given the US Food and Drug Administration (FDA) on March 21 approved Telix's second diagnostic, Gozellix (also for prostate cancer). Telix hopes to launch Gozellix in the US in the current quarter, having appointed RLS and Cardinal Health as distribution partners. Bursting development pipeline Meanwhile, Telix expects FDA approval for its brain imaging candidate Pixclara by the end of this week – April 26. As per the FDA's timetable, the agency should approval Telix's kidney cancer imaging candidate Zircaix by August 27. Investors should expect an initial safety and dosing readout on phase III trial results for Telix's prostate cancer therapy (as opposed to diagnostic) in the current half. Telix also hopes to submit an FDA investigational new drug application for its kidney cancer therapeutics, in view of a late-stage pivotal trial. Adding to Telix's packed agenda, the company has earlier stage programs for a brain cancer therapy (phase II) and advanced, metastatic soft tissue sarcoma (phase I). Telix shares this morning rocketed as much as 15%, but they are still well shy of their February 25 zenith of just over $31. Investors may question just how much of the excitement is factored into Telix's $9.7 billion market capitalisation. Island promises trial results next month Island Pharmaceuticals (ASX:ILA) investors won't have to wait too much longer for results from the second stanza of the company's phase 2a/b dengue fever trial. The 2a phase assessed the preventative qualities of Island's drug candidate ISLA-101 in four undiseased subjects, one of whom was administered a placebo. The drug was deemed safe, with 'evidence of anti-dengue activity". The 2b stage had enrolled ten patients who are administered a weakened form of the virus. Eight of them are administered ISLA-101, with two receiving a placebo. Pharmacokinetic tests showed the drug reached the bloodstream in desired quantities. Next month's results will outline the efficacy. Carried by mosquitos, dengue fever has become a major health problem as it spreads at a rate that makes cane toads look slothful. Race to start cancer trial Race Oncology (ASX:RAC) expects to treat the first patient in its local phase 1 trial that tests its drug candidate RC-220 alongside a common chemotherapy agent. RC-220 is a reformulated version of bisantrene, which was developed as a leukemia drug in France in the 1980s, but was never commercialised for reasons lost in the midst of time. RC-220 shows promise not just for its cancer-busting properties, but its ability to protect the heart from the dire effects of chemotherapy. The trial custodians are treating initial patients at the Southside Cancer Care Centre at Sydney's Miranda. Race has also gained ethics approval to open sites at the Gosford and Wyong hospitals. Race's March quarterly report discloses cash of $17.12 million, with 70% of the $1.67 million quarterly burn devoted to R&D. 'This prudent cash management enables Race to fund all announced clinical and preclinical programs through calendar 2026," the company says. Race costs the circa 53-patient RC-220 trial at $8.58 million. An FDA decision to dye for The latest decision by US health czar Robert F. Kennedy Junior and FDA commissioner Marty Makary could be one of their least controversial. The FDA has banned petroleum-based synthetic dyes from food, as used sweets, soft drinks and other stuff that isn't good for you. Depending on their colour, dyes are thought to be carcinogenic or cause behavioural problems in some children. One of President Biden's last acts in power was to ban an especially controversial red dye from food and ingested drugs, after the additive was found to cause cancer in rats. Technically, the dye no longer is 'generally recognised as safe'.
Khaleej Times
20-03-2025
- Health
- Khaleej Times
EU health regulator clears use of AI tool in fatty liver disease trials
A European Medicines Agency committee, on Thursday, accepted the use of an artificial intelligence (AI) tool called AIM-NASH in clinical trials to help identify the severity of a type of fatty liver disease. The condition, called metabolic dysfunction-associated steatohepatitis, or MASH, is a difficult-to-treat disease that affects around 1.5 per cent to 6.5 per cent of adults in the US, according to the American Liver Foundation. The AI-based AIM-NASH tool employs a machine learning model trained on more than 100,000 annotations from 59 pathologists who assessed over 5,000 liver biopsies across nine large clinical trials. The EMA's human medicines committee (CHMP) said evidence showed the AI tool can reliably determine disease activity from biopsies with less variability than the current standard in trials that rely on a consensus of three pathologists. On that basis, the CHMP concluded, it can accept evidence generated by the tool as scientifically valid, which will help researchers obtain clearer evidence on the benefits of new treatments in clinical trials. Currently, Madrigal Pharmaceuticals', Rezdiffra is the only US-approved drug for MASH. Drugmakers such as Novo Nordisk and Eli Lilly are also conducting trials with their blockbuster GLP-1 treatments to treat patients with the liver disease.
